Issued to Teva Pharmaceuticals USA, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 26, 2017Application
NDA 505b1 • 210063
Product
CLIGAVYX
Company
Teva Pharmaceuticals USA, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2020
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Safety and adverse events, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Teva Pharmaceuticals USA, Inc. on October 26, 2017.
NDA 210063 is the application under which FDA issued this complete response letter for CLIGAVYX to Teva Pharmaceuticals USA, Inc.. It was reviewed by FDA Other. The letter is dated October 26, 2017.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.